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FDA 510(k)

RESOLVE BILIARY DRAINAGE CATHETER

K-Number: K063733 · 2007-11-14

Decision Date2007-11-14
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

RESOLVE BILIARY DRAINAGE CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 2007-11-14 under 510(k) number K063733. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESOLVE BILIARY DRAINAGE CATHETER?

RESOLVE BILIARY DRAINAGE CATHETER is a medical device that received FDA 510(k) clearance on 2007-11-14. The listed applicant is Merit Medical Systems, Inc.. The 510(k) number is K063733.

When did RESOLVE BILIARY DRAINAGE CATHETER receive FDA 510(k) clearance?

RESOLVE BILIARY DRAINAGE CATHETER received FDA 510(k) clearance on 2007-11-14, under 510(k) number K063733.

Who is the listed applicant for RESOLVE BILIARY DRAINAGE CATHETER?

The FDA 510(k) record lists Merit Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RESOLVE BILIARY DRAINAGE CATHETER?

The FDA product code for RESOLVE BILIARY DRAINAGE CATHETER is FGE.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Other records listing Merit Medical Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 159 devices →

Related Devices (Code: FGE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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